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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Failure to Sense (1559); Inaccurate Synchronization (1609)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the aware date.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.
 
Event Description
It was reported that the customer called to ask about fiber optic (fo) catheters.They reported they had a patient on the cs300 intra-aortic balloon pump (iabp) and when the cuff pressure dropped due to the patient's condition, the intra-aortic balloon (iab) did not drop.The difference in pressure was enough that the customer was concerned.They have recently begun using fiber-optic iabs and are not comfortable with them.The getinge representative advised it can be difficult to compare the cuff (one moment in time) to the continuous pressure monitoring of the iabp.The getinge representative also advised the customer to consider pressing the zero key at any time to confirm pressure.The cuff was showing 120 systolic and the iabp was in the 180s.The customer reported that once the patient is removed from the iabp, it will be sent to the biomed for service.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that the customer called to ask about fiber optic (fo) catheters.They reported they had a patient on the cs300 intra-aortic balloon pump (iabp) and when the cuff pressure dropped due to the patient's condition, the intra-aortic balloon (iab) did not drop.The difference in pressure was enough that the customer was concerned.They have recently begun using fiber-optic iabs and are not comfortable with them.The getinge representative advised it can be difficult to compare the cuff (one moment in time) to the continuous pressure monitoring of the iabp.The getinge representative also advised the customer to consider pressing the zero key at any time to confirm pressure.The cuff was showing 120 systolic and the iabp was in the 180s.The customer reported that once the patient is removed from the iabp, it will be sent to the biomed for service.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.The customer reported that unfortunately they do not have any additional information other than the patient was on the iabp, and that the iabp itself did not require any maintenance.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10186950
MDR Text Key196259712
Report Number2249723-2020-00951
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight70
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